Kornimate/medical-research-clean huggingface dataset:
patient centered care situation and health-related quality of life by patients with psoriasis, urticaria or lupus

Conditions: Quality of Life

Summary: this study is based on a survey about the patient centered care situation and health-related quality of life of patients with diagnoses psoriasis, urtikaria or lupus erythematodes. detection of relevant parameters of quality of life by these patients serves for the detection of psychosocial burden of the mentioned skin diseases, thus gaining an increasing importance for prospective economic issues. this survey is a behaviorally based questionnaire for patients with the above diseases and addresses activities such as sleep and rest, mobility, recreation, home management, emotional behavior, social interaction, and the like.

the care of patients with the above indications is based on a wide variety of available therapies. this study is based on a survey about the patient centered care situation and health-related quality of life of patients with diagnoses psoriasis, urtikaria or lupus erythematodes. therefore a cross-sectional survey will be done of patients with the above diseases from non-urban practices vs. urban practices (university hospital). an adequate diagnosis and treatment of psorisasis, urticaria or lupus erythematodes is often problematic due to the diverse and complex organ manifestations. however adequate diagnosis and appropriate treatments of these diseases is often conducted by various medical specialists in both outpatient and in-patient care. lack of access and ability of the rural population to get an appropriate therapy may lead by these patients to false diagnosis or a therapeutic oversupply of an only symptom-oriented therapy. furthermore the partly chronic character in the above mentioned diseases with recurrent symptoms, connected with prolonged itching periods and long-lasting treatments by these patients can lead to both emotional, mental stress and physical isolation. this situation does not only affect the health but also the overall quality of life of these patients. therefore this study addresses several factors concerning the patient's perceived health status and to detect changes or differences in health status occurring between groups (patients from non-urban practices vs urban practices)

Eligibility criteria:
inclusion criteria: * voluntary consent by written and oral explanation. * patients with the diseases psoriasis, urticaria or lupus exclusion criteria: * children and adolescents \< 18 years * pregnancy and breast feeding period of women * history of abuse of alcohol, drugs or other substances, or factors that limit the ability to cooperate and compliance in the study

Keywords: psoriasis urticaria lupus erythematodes qualtiy of life
maternal and perinatal pregnancy outcome in women with heterozygous hemoglobinopathies

Conditions: Heterozygous Haemoglobinopathy

Summary: this retrospective study aims to investigate pregnancy outcome in women with heterozygous hemoglobinopathies (regarding gestational diabetes, cholestasis and urinary tract infections) and to analyze if there are aggravated maternal and/or perinatal risks.


Eligibility criteria:
inclusion criteria: * pregnant women with or without heterozygous hemoglobinopathy exclusion criteria: * refusal of study participation

Keywords: pregnancy gestational diabetes cholestasis in pregnancy urinary tract infection in pregnancy
exercise training and plasma lipoproteins in man

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Hypertension; Myocardial Ischemia; Obesity

Summary: to determine the effects in moderately obese subjects of weight loss by combined dieting and exercise training on risk factors for coronary artery disease including lipoprotein lipids, apoproteins and blood pressure.

background: evidence appears to be fairly conclusive that obesity has adverse effects on health and longevity when the relative body weight is 40 percent above desirable weight based on insurance industry tables of weights. the close association between obesity, hypertension, hypercholesterolemia, non-insulin dependent diabetes mellitus, an excess of certain cancers and other medical problems makes it imperative that interventions be directed to change the lifestyles and behaviors of individuals who are overweight. the stanford weight control project (swcp) trial examined the effects of weight loss on cardiovascular disease risk factors. the stanford weight control project (swcp) randomized 155 overweight, sedentary, non-smoking men, aged 30-59 years, to one of three groups. fifty-one were assigned to weight loss through dieting, 52 to weight loss through exercise, and 52 to a control, non-intervention group. follow-up continued through july 1989. design narrative: subjects were randomized to a control group, a hypocaloric national cholesterol education program (ncep) diet, or to a hypocaloric ncep diet with exercise. one hundred nineteen of the men and 112 of the women returned for testing after one year.

Eligibility criteria:
men and women, ages 25-49. subjects were overweight with blood pressure less than 160/95 mm hg and total cholesterol less than 260 mm/dl.
active case finding of clinical hand foot mouth disease in children aged 6 months old to 18 years old in indonesia

Conditions: Hand, Foot and Mouth Disease

Summary: an observational study of active case surveillance to identify the pathogens of clinically diagnosed hfmd cases aged 6 months to 18 years old recruited from puskesmas and hospitals in indonesia.

every time suspected case of hfmd presented to the hospital, the pediatrician will inform the patient to enroll in the study. after the subject signs the informed consent, the pediatrician will give the subject designated number to enroll to the study. after gathering general information, medical history, and physical examination, the eligibility of participants will be assessed. the subject that fulfills the eligibility criteria will be enrolled in the study. all participants will collect stool sample or rectal swab to be tested with pcr test for ev71, ca (planned serotypes 16/10/6). if the result is positive, the sample will be further tested with genotype sequencing of ev71 and coxa. for subject with respiratory symptom, skin lesion or encephalitis, extra pcr testing will be collected for pcr testing. blood sample will also be collected from all subjects. only 20 subjects with positive pcr result that will be tested for svnt and prnt. two weeks following participant recruitment, study staff will contact the participant by phone and document the outcome of the disease as well the subject's condition.

Eligibility criteria:
inclusion criteria: * clinically diagnosed hfmd children of either sex, aged 6 months - 18 years old in the study sites * the participant's parent/ legally accepted representative (lar) could understand and sign a documented informed consent voluntarily before the study procedures. exclusion criteria: * na.
a multi-center post-market surveillance registry

Conditions: Coronary Artery Disease

Summary: this multicenter, prospective, observational registry will evaluate the safety and performance of the cypher select™ sirolimus-eluting coronary stent, and of all future generation of commercially approved cordis sirolimus-eluting stents (ses), in routine clinical practice. its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and major adverse cardiac events (mace). additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (isr), acute myocardial infarction (ami) and multivessel coronary disease.

the data will be collected in consecutive subjects treated with commercially available product and following standard clinical practice. this registry will be limited to subjects who have received only the cypher select™ sirolimus-eluting coronary stent during the index procedure. while no inclusion or exclusion criteria have been specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up. all subjects should be treated according to the instruction for use (ifu) including conduct of the stenting procedure, application of antiplatelet medication and any other medical therapy should be provided according to local usual practice. data collection (electronic data capture), data management, statistical analyses, monitoring and core laboratory evaluations will be assigned to independent organizations.

Eligibility criteria:
inclusion criteria: * this registry will be limited to subjects who have received only the cypher select™ sirolimus-eluting coronary stent during the index procedure; * males and females; exclusion criteria: * none.
emerging adults who use alcohol and marijuana

Conditions: Alcohol Use; Marijuana Use; Sexually Transmitted Infections

Summary: the purpose of this study is to if a brief motivational intervention, compared to health education sessions, reduces alcohol and marijuana use and is related to fewer sexually transmitted infections (sti)in emerging adults who are engaging in alcohol and marijuana use.


Eligibility criteria:
inclusion criteria: * be between the ages of 18 and 25 * binge drink (5 or more drinks in a 2-hour period for men, 4 or more for women) at least monthly * use marijuana at least weekly * have been heterosexually active in the past six months * are not married * have not been living with a sexual or romantic partner for more than 6 months * be english speaking * reside within 20 miles of providence, ri and plans to stay in the geographic area for the next 15 months * provide contact information for at least two verifiable locator persons exclusion criteria: * have dsm-iv diagnosis of drug abuse or dependence (other than nicotine, marijuana) * have dsm-iv diagnosis of alcohol dependence

Keywords: alcohol use marijuana use sti
the effect of valerian on insomnia in menopausal women

Conditions: Menopausal Women; Insomnia

Summary: menopausal women often complain that it is difficult to fall asleep and easy to wake up at night and early in the morning and it is in the middle of night difficult to fall asleep again. if the above symptoms persist for at least three months and occur at least three times a week, plus the impact on daytime work and rest, and meet the international classification of sleep disorders (icsd-3) )'s s "insomnia" diagnostic criteria. according to statistics, 30% to 60% of women face sleep disorders during menopause.

the investigators expect to receive outpatient admissions in the hospital attached to china medical university. menopausal women aged 45-60 years old who have been diagnosed with insomnia who meet criteria of international classification of sleep disorders (icsd-3) will be randomly assigned for clinical trials. patients will take two valerian capsules (1000mg/day) per day for four weeks. pittsburgh sleep index (psqi) will be used to evaluate subjective sleep quality. tcm patterns will be evaluated by three physicians of tcm gynecology independently before and after taking valeriana. the data will conduct a biological analysis to compare the difference in sleep quality between the trial group and the control group.

Eligibility criteria:
inclusion criteria: 1. 45〜60 years old, and is menopaused for at least 1 year。 2. meet the criteria of icsd-3 for insomnia 3. psqi \> 5 exclusion criteria: 1. psychiatry disease 2. heart, brain, liver diseases 3. insomnia is caused by diseases. 4. steroid used within 6 months 5. pregnant or breastfeeding

Keywords: menopause insomnia valerian
shift work, heredity, insulin, and food timing study

Conditions: Shift Work Type Circadian Rhythm Sleep Disorder; Diabetes Mellitus, Type 2; Circadian Rhythm Sleep Disorder, Shift Work Type; Insulin Resistance

Summary: the purpose of this study is to determine whether night time eating that coincides with elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the mtnr1b risk allele.

preliminary observations suggest that food intake coincident with high melatonin levels leads to impaired glucose tolerance-particularly in mtnr1b risk allele carriers. our objectives are to determine the effect of concurrent food intake and melatonin on glucose tolerance; and to assess the role of mtnr1b single nucleotide polymorphism (snp)\*melatonin interaction in this deleterious effect. our central hypothesis is that concurrent high melatonin levels and food intake, commonly experienced in night shift workers, cause long-term impairment of glucose tolerance and that this effect is worse in carriers of the mtnr1b type 2 diabetes (t2d) risk snp than in non-carriers. the results of this proposal will help to clarify an ongoing controversy about the role of melatonin in glucose tolerance, and will help to develop novel strategies in the prevention and treatment of t2d, especially in shift workers, night eaters, and mtnr1b risk allele carriers.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female * 18-60 years * currently employed (night shift workers and day workers), graduate students, part-time workers, or unemployed * able and willing to give consent relevant to genetic investigation exclusion criteria: * currently taking any medications for the treatment of diabetes * currently taking medications known to affect glycemic parameters, such as glucocorticoids, growth hormone or fluoroquinolones * pregnant, nursing or at risk of becoming pregnant * chronic renal failure, hepatic diseases, or cancer diagnoses * bulimia diagnosis, prone to binge eating * eating disorder diagnosis such as anorexia, binge eating, or bulimia * with psychiatric illness, such as schizophrenia or bipolar affective disorder * blind * history of bariatric surgery

Keywords: diabetes mellitus, type 2 insulin resistance shift work circadian rhythms mtnr1b
the impact of repetitive transcranial magnetic stimulation on the prognosis of elderly surgical patients

Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction; Chronic Post-surgical Pain

Summary: exploring the effects of repeated transcranial magnetic stimulation (rtms) during the perioperative period on the incidence of postoperative delirium, postoperative cognitive dysfunction, and chronic postoperative pain in elderly patients, as well as its possible mechanisms.

patients are recruited one week prior to the trial commencement, during which they are informed about the experimental protocol and associated risks. after obtaining informed consent and signatures, they are enrolled as study participants.patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham rtms group) and the intervention group (rtms group, with rtms intervention applied in the pacu after surgery) in a double-blind manner (with rtms intervention and postoperative follow-up conducted by different researchers). note: this trial includes three co-primary outcomes-postoperative delirium (pod), postoperative cognitive dysfunction (pocd), and chronic postoperative pain (cpsp). to account for the different nature and timelines of these outcomes, the study was designed to include two parallel patient cohorts under a unified protocol: 1. elderly patients undergoing gastrointestinal surgery are enrolled primarily for the evaluation of pod, a short-term outcome assessed within 3 days postoperatively. 2. elderly patients undergoing thoracic surgery are enrolled to evaluate pocd (at 1 month) and cpsp (at 3 months), which are longer-term outcomes. these two patient cohorts are studied concurrently but analyzed separately according to outcome-specific follow-up timelines and sample size estimations. a total of 122 gastrointestinal surgery patients were enrolled and analyzed for pod. the maximum estimated sample size is for the pocd and cpsp cohort (n=230). results will be reported in phases corresponding to the completion of each outcome assessment.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years; * asa ≤ 3; * elective surgery patients. exclusion criteria: * refusal to sign the consent form; * mini-mental state examination (mmse) score \< 15; * preoperative neuropsychiatric diseases and history of neurological or psychiatric disorders; * preoperative cranial or scalp injuries; * history of drug or alcohol abuse; visual or auditory impairments, communication difficulties; presence of metallic implants in the body; preoperative history of severe cardiovascular disease or severe liver or kidney dysfunction.
outpatient foley catheter for induction of labor in nulliparous for prolonged pregnancy

Conditions: Induction of Labour; Prolonged Pregnancy

Summary: 15 to 20 % of nulliparous needs an induction at term. none study has evaluated foley catheter induction at home versus expectative in this population


Eligibility criteria:
inclusion criteria: * prolonged pregnancy (d+4) nulliparous no complication during pregnancy location near th hospital (20 mn by car) bishop \< 6 exclusion criteria: * medical history small for gestationnal age prom live alone

Keywords: induction of labour nulliparous prolonged pregnancy foley catheter vaginal birth
serious game versus online course to pre-train medical students on the management of an adult cardiac arrest.

Conditions: Education, Medical, Undergraduate; Out-of-Hospital Cardiac Arrest; Simulation Training

Summary: the objective of this study is to compare two forms of pre-training (an online narrative presentation and a serious game) to prepare 2nd year medical students for a hands-on training with physical simulators about out-of-hospital cardiac arrest management.

technology-enhanced simulation allows mastery learning. mastery learning is a variety of competency-based education which has demonstrated its efficacy for skills acquisition and their transfer to actual settings. while traditional education defines fixed learning time and allows outcomes to vary, in mastery learning, all trainees must achieve a predefined level of proficiency while their learning time can vary. the main limitation of mastery learning is that it takes more time than non-mastery learning. this is of concern because the main barrier to simulation-based training is the lack of faculty time. thus, new solutions should emerge to conciliate mastery learning and time constraints on physical simulators. pre-training with a "simulation game" may be a mean to reach this objective. simulation games are serious games which are at the cross roads between (1) educational games which are "applications using the characteristics of video and computer games to create engaging and immersive learning experiences", and (2) simulation, the imitation of situations which can be encountered in real-life. they combine the advantages of educational games (active, personalized learning) and simulation (realistic and safe environment for experiential learning). by contrast, pre-training with an online course using a powerpoint presentation with voiceover narration lecture is both passive and abstract. the objective of this study is to evaluate the time-efficiency of pre-training using a simulation game versus an online course to reach mastery learning in the management of an adult out-of-hospital cardiac arrest.

Eligibility criteria:
inclusion criteria: * second-year medical students from the medical schools of paris descartes and paris diderot university who are not opposed to participate in the study. exclusion criteria: * opposition to participate in the study
ocular tissue levels of 1.5% levofloxacin ophthalmic solution compared to an active comparator

Conditions: Cataract

Summary: compare ocular tissue levels following topical ocular instillation of 1.5% levofloxacin ophthalmic solution or an active comparator in subjects undergoing cataract surgery.


Eligibility criteria:
inclusion criteria: * capable of instilling eye drop * scheduled for cataract surgery with intraocular lens (iol) implantation * be medically cleared for surgery * women must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study * women of childbearing potential must have a negative urine pregnancy test at screening. * willing to adhere to the prohibitions and restrictions specified in this protocol. * subjects (or his/her legally acceptable representative) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. exclusion criteria: * known allergy or other contraindication to the test article(s) or their components. * presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters. * history of or presence of any corneal pathology or disease * presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection. * history of severe dry eye syndrome. * history or evidence of previous ocular surgery in the operative eye. * history of any significant illness that could be expected to interfere with the study parameters. * use of disallowed therapies (systemic or topical): * fluoroquinolone anti-infective agents (systemic or topical) within 2 weeks of visit 1 or anytime after visit 1 for the duration of the study; * topical ophthalmic preparations (including tear substitutes and rewetting drops), within 1 week of visit 1 or anytime after visit 1 for the duration of the study (other than the study medication as restricted above), with the exception of non-steroidal topical ophthalmic drops * use of contact lenses in the 2 weeks prior to the study and for the duration of the study. * received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment. * pregnant or breast-feeding. * any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study. * employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Keywords: aqueous humor penetration by anti-infectives
a study to evaluate the safety and efficacy of ombitasvir/abt-450/ritonavir with sofosbuvir with or without ribavirin in adults with chronic hepatitis c virus infection

Conditions: Chronic Hepatitis C Virus Infection

Summary: the purpose of this study is to evaluate the safety and efficacy of ombitasvir (obv)/paritaprevir (ptv)/ritonavir (r) with sofosbuvir (sof) with or without ribavirin (rbv) in adults with genotype 2 chronic hepatitis c virus (hcv) infection or genotype 3 hcv infection with or without cirrhosis.


Eligibility criteria:
inclusion criteria: 1. chronic hcv infection prior to study enrollment. 2. screening laboratory results from the central clinical laboratory indicating hcv genotype 2 or 3 infection only (no mixed genotype). 3. absence or presence of cirrhosis. 4. if cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (hcc) exclusion criteria: 1. positive screen for hepatitis b surface antigen or anti-human immunodeficiency virus antibody 2. recent (within 6 months prior to study drug administration) history of drug or alcohol abuse. 3. current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-hcv therapy (other than interferon, pegifn, rbv, and or sof) including previous exposure to telaprevir, boceprevir, abt-450, or ombitasvir (abt-267). 4. subjects without cirrhosis: any current or past clinical evidence of cirrhosis. 5. abnormal lab tests. 6. females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant

Keywords: hepatitis c virus genotype 2 chronic hepatitis c genotype 3 non-cirrhotic cirrhotic